Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs
NCT ID: NCT00050063
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
78 participants
OBSERVATIONAL
2004-05-31
Brief Summary
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Detailed Description
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Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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Therapeutic vaccinations from A5058s
Participants will receive assigned interventions assigned in study A5058s.
Eligibility Criteria
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Inclusion Criteria
* Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
* No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
* CD4+ T-cell count \> 300 cells/mm3 obtained within 30 days prior to study entry
* HIV-1 RNA \< 500 copies/ml obtained within 30 days prior to study entry
* Agreement to use approved methods of contraception
Exclusion Criteria
* Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
* Symptomatic chronic infections other than HIV
* Malignancy that may require systemic therapy
* History of lymph node irradiation
* Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
* Hydroxyurea within 30 days prior to study entry
* Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
* Active drug or alcohol use or dependence that would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Spyros Kalamus, M. D.
Role: STUDY_CHAIR
Vanderbilt University Medical Center
Fred Valentine, M. D.
Role: STUDY_CHAIR
NYU MEDICAL CENTER
Locations
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Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, United States
Countries
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References
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Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
Carcelain G, Tubiana R, Samri A, Calvez V, Delaugerre C, Agut H, Katlama C, Autran B. Transient mobilization of human immunodeficiency virus (HIV)-specific CD4 T-helper cells fails to control virus rebounds during intermittent antiretroviral therapy in chronic HIV type 1 infection. J Virol. 2001 Jan;75(1):234-41. doi: 10.1128/JVI.75.1.234-241.2001.
Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80. doi: 10.1056/NEJM200102153440702.
Ruiz L, Carcelain G, Martinez-Picado J, Frost S, Marfil S, Paredes R, Romeu J, Ferrer E, Morales-Lopetegi K, Autran B, Clotet B. HIV dynamics and T-cell immunity after three structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F19-27. doi: 10.1097/00002030-200106150-00001.
Garcia F, Plana M, Vidal C, Cruceta A, O'Brien WA, Pantaleo G, Pumarola T, Gallart T, Miro JM, Gatell JM. Dynamics of viral load rebound and immunological changes after stopping effective antiretroviral therapy. AIDS. 1999 Jul 30;13(11):F79-86. doi: 10.1097/00002030-199907300-00002.
Other Identifiers
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10184
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5172
Identifier Type: -
Identifier Source: secondary_id
A5172
Identifier Type: -
Identifier Source: org_study_id